Rifapentine

Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology (12.4) ] .

• PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) PRIFTIN is indicated for the treatment of latent tuberculosis infection (LTBI) caused by M.ICD-10: A15.9

• Known hypersensitivity to any rifamycin. ( 4.1 ) 4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.contraindicated

Active pulmonary tuberculosis: PRIFTIN should be used in regimens consisting of an initial 2 month phase followed by a 4 month continuation phase. ( 2.1 ) Initial phase (2 Months): 600 mg twice weekly for two months as directly observed therapy (DOT), with no less than 72 hours between doses, in combination with other antituberculosis drugs. ( 2.1 ) Continuation phase (4 Months): 600 mg once weekly for 4 months as directly observed therapy with isoniazid or another appropriate antituberculosis agent. ( 2.1 ) Latent tuberculosis infection: PRIFTIN should be administered in combination with isoniazid once weekly for 12 weeks as directly observed therapy. ( 2.2 ) Adults and pediatric patients ≥12 years: PRIFTIN (based on weight, see table below) and isoniazid 15 mg/kg (900 mg maximum). ( 2.2 ) Pediatric patients 2 to 11 years: PRIFTIN (based on weight, see table below) and isoniazid 25 mg/kg (900 mg maximum). ( 2.2 ) Weight range PRIFTIN dose Number of PRIFTIN tablets 10–14 kg 300 mg 2 14.1–25 kg 450 mg 3 25.1–32 kg 600 mg 4 32.1–50 kg 750 mg 5 >50 kg 900 mg 6 For Latent Tuberculosis Infection, the maximum recommended dose of PRIFTIN is 900 mg once weekly for 12 weeks. ( 2.2 ) Take with food. Tablets may be crushed and added to semi-solid food. ( 2.3 ) 2.1 Dosage in Active Pulmonary Tuberculosis PRIFTIN is only recommended for the treatment of active pulmonary tuberculosis caused by drug-susceptible organisms as part of regimens consisting of a 2-month initial phase followed by a 4-month continuation phase.

Hepatotoxicity: Monitor for symptoms of liver injury and discontinue PRIFTIN if signs or symptoms or liver injury occur. ( 5.1 ) Hypersensitivity: Discontinue PRIFTIN if signs or symptoms of hypersensitivity reaction occur. ( 5.2 ) Severe cutaneous adverse reactions: Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. ( 5.3 ) Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regimen with isoniazid in HIV-infected patients. Monitor for signs or symptoms of relapse in patients with cavitary lesions or bilateral disease. ( 5.4 , 14.1 ) Paradoxical Drug Reactions: If worsening of symptoms or signs occur during antimycobacterial treatment, consider paradoxical drug reaction in the differential diagnosis, and monitor or treat accordingly. ( 5.5 ) Drug Interactions: May interact with drugs metabolized by CYP450. ( 5.6 , 7.1 , 7.4 ) Discoloration of body fluids: May permanently stain contact lenses or dentures red-orange. ( 5.7 ) Clostridioides difficile –associated diarrhea: Evaluate if diarrhea occurs. ( 5.8 ) Porphyria: Avoid use in patients with porphyria. ( 5.9 ) 5.1 Hepatotoxicity Elevations of liver transaminases may occur in patients receiving PRIFTIN [see Adverse Reactions (6.1) ] . Patients on PRIFTIN should be monitored for symptoms of liver injury.

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Drug Reactions [see Warnings and Precautions (5.5) ] Discoloration of Body Fluids [see Warnings and Precautions (5.7) ] Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions (5.8) ] Porphyria [see Warnings and Precautions (5.9) ] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache. The most common adverse reaction (3% and greater) with the regimen for latent tuberculosis infection is hypersensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Lactation: Monitor infants exposed to PRIFTIN through breast milk for irritability, prolonged unexplained crying, yellowing of the eyes, changes in color of the urine or stool. ( 8.2 ) Pediatrics: Safety and effectiveness in treating active pulmonary tuberculosis in pediatric patients under the age of 12 years have not been established. ( 8.4 ) 8.1 Pregnancy Risk Summary Based on animal data, PRIFTIN may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with PRIFTIN use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant. Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data ) . There are risks associated with active tuberculosis during pregnancy.

Metabolism

When oral doses of PRIFTIN were administered once daily or once every 72 hours to healthy volunteers for 10 days, single dose AUC (0–∞) of rifapentine was similar to its steady-state AUC ss (0–24h) or AUC ss (0–72h) values, suggesting no significant auto-induction effect on steady-state pharmacokinetics of rifapentine. Steady-state conditions were achieved by day 10 following daily administration of PRIFTIN 600 mg.

While there is no experience with the treatment of acute overdose with PRIFTIN, clinical experience with rifamycins suggests that gastric lavage to evacuate gastric contents (within a few hours of overdose), followed by instillation of an activated charcoal slurry into the stomach, may help adsorb any remaining drug from the gastrointestinal tract. Rifapentine and 25-desacetyl rifapentine are 97.7% and 93.2% plasma protein bound, respectively. Rifapentine and related compounds excreted in urine account for only 17% of the administered dose, therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifapentine from the body of a patient with PRIFTIN overdose.

• Jun 22, 1998NDANDA021024Sanofi Aventis Us

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Priftin, Tablet, Film Coated, 150 mg (NDC 0088-2102-24)Active
  Sponsor: Sanofi-Aventis U.S. LLC
  Updated Apr 29, 2026

1. 1Pyrexia6613%
2. 2Drug Interaction6513%
3. 3Nausea5210%
4. 4Fatigue428.4%
5. 5Hypertension408.0%
6. 6Vomiting397.8%
7. 7Off Label Use377.4%
8. 8Headache326.4%
9. 9Rash326.4%
10. 10Dizziness316.2%
11. 11Dyspnoea316.2%
12. 12Influenza Like Illness275.4%
13. 13Chills234.6%
14. 14Hypotension234.6%
15. 15Myalgia224.4%

The 10 most recently updated of 75 ClinicalTrials.gov registrations naming Rifapentine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 144 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07124559updated 2026-06-12
• Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,530 enrolled · Johns Hopkins University
  NCT06568484updated 2026-06-03
• Shortened Regimen for Drug-susceptible TB in Children
  Recruiting · Phase 3 · Interventional · 860 enrolled · Johns Hopkins University
  NCT06253715updated 2026-06-01
• Short-Course Regimens for DS-PTB in AIDS Patients
  Not yet recruiting · Interventional · 148 enrolled · Shanghai Public Health Clinical Center
  NCT07608172updated 2026-05-27
• A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
  Not yet recruiting · Phase 2 · Interventional · 900 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07595042updated 2026-05-19
• Tuberculosis Clinical Trials Consortium Study 35
  Completed · Phase 1 · Phase 2 · Interventional · 62 enrolled · Centers for Disease Control and Prevention
  NCT03730181updated 2026-05-14
• Shorter and Safer Treatment Regimens for Latent TB
  Recruiting · Phase 2 · Phase 3 · Interventional · 1,800 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT06498414updated 2026-05-11
• Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
  Recruiting · Phase 2 · Phase 3 · Interventional · 3,400 enrolled · Centers for Disease Control and Prevention
  NCT03474029updated 2026-05-06
• Asymptomatic TB With Innovative Modified Short-course Regimens
  Recruiting · Phase 4 · Interventional · 426 enrolled · Huashan Hospital
  NCT06153069updated 2026-02-11
• Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women
  Not yet recruiting · Phase 1 · Interventional · 60 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT07069582updated 2026-02-10

Frequently asked questions

How does Rifapentine work?

Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology (12.4) ] .

What is Rifapentine used for?

According to FDA labeling, Rifapentine carries indications including: PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) PRIFTIN is indicated for the treatment of latent tuberculosis infection (LTBI) caused by M.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rifapentine?

Rifapentine is classified as Antibiotics, Rifamycin Antimycobacterial, Nucleic Acid Synthesis Inhibitors, Cellular Growth Phase Reduction, Decreased Protein Synthesis, Decreased RNA Replication, Decreased Transcription to RNA.

What are the brand names for Rifapentine?

Rifapentine is marketed under brand names including Priftin.

What are the contraindications for Rifapentine?

Rifapentine labeling lists contraindications including: Known hypersensitivity to any rifamycin. ( 4.1 ) 4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.. Always consult the full prescribing information and a clinician.